NCT04807348|CompletedPhase 3

Chiglitazar Added to Metformin for Type 2 Diabetes

A Randomised Double-blind Placebo Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Chiglitazar Added to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy (RECAM)

Chipscreen Biosciences, Ltd.ClinicalTrials.gov

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1 other identifier

CGZ303

Study Type

interventional

Target

533

Locations

1 country

Sites

Timeline

RegisteredMar 2021

StartedJul 2021

CompletionFeb 2023

Brief Summary

The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

533

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes

Timeline

Completed

Started Jul 2021

Geographic Reach

1 country

50 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

March 17, 2021

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed

4 months until next milestone

Study Start

First participant enrolled

July 6, 2021

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed

Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

March 17, 2021

Last Update Submit

July 11, 2024

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

percentage of HbA1c change from baseline
central lab test
24 weeks

Secondary Outcomes (5)

Changes in blood fasting plasma glucose level from baseline
12 and 24 weeks
Changes of HOMA-the IR value from baseline
12 and 24 weeks
Changes of blood lipids level from baseline
12 and 24 weeks
percentage of AEs
28 weeks
number of participants with lab abnormality
24 weeks

Study Arms (3)

Chiglitazar sodium 32mg QD+metformin

EXPERIMENTAL

Chiglitazar 32mg qd+metformin

Drug: Chiglitazar 32mgDrug: Metformin Hydrochloride

Chiglitazar sodium 48 mg QD+metformin

EXPERIMENTAL

Chiglitazar 48 mg qd+metformin

Drug: Chiglitazar 48mgDrug: Metformin Hydrochloride

placebo+metformin

PLACEBO COMPARATOR

placebo+metformin

Drug: PlaceboDrug: Metformin Hydrochloride

Interventions

Chiglitazar 32mgDRUG

Administrated once daily

Also known as: Bilessglu, CS038

Chiglitazar sodium 32mg QD+metformin

Chiglitazar 48mgDRUG

Administrated once daily

Also known as: Bilessglu, CS038

Chiglitazar sodium 48 mg QD+metformin

PlaceboDRUG

Placebo of Chiglitazar

Also known as: Chiglitazar simulator

placebo+metformin

Metformin HydrochlorideDRUG

most tolerable dose

Also known as: Glucophage

Chiglitazar sodium 32mg QD+metforminChiglitazar sodium 48 mg QD+metforminplacebo+metformin

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

) Provide a signed and dated informed consent form;
) Men and women aged ≥ 18 years and ≤ 75 years;
) According to the World Health Organization ( the WHO ) 1999 criteria for the diagnosis of type 2 diabetes;
) After metformin stable dose monotherapy (≥1500 mg/day or maximum tolerated dose, but the maximum tolerated dose not \< l000 mg/day) for at least 8 weeks;
) The local HbA1c value during the screening period: 7.5% ≤ HbA1c ≤ 11% ;
) The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c ≤ 10.5% ;
) BMI ≥ 18.5 kg/m2 and ≤ 35 kg/m 2 ;
) Fasting C- peptide ≥ 0.5 nmol/L ;
) Women of Childbearing Potential ( WOCBP ) should take reliable contraceptive measures at least 1 month before the screening, during the entire trial, and within 3 months after completing the trial; male subjects should take reliable contraceptive measures to avoid making their sexual partners to pregnant during the entire trial and within 3 months after the trial.

You may not qualify if:

) Type 1 diabetes;
) Pregnancy or lactation;
) The New York Heart Association (NYHA ) defines congestive heart failure as grade III or IV ;
) Significant history of cardiovascular and cerebrovascular diseases within 6 months before screening, defined as myocardial infarction, coronary artery bypass graft or angioplasty, valvular disease or repair, unstable angina, transient brain Ischemic attack, or cerebrovascular accident;
) Suffered from malignant tumors (except cured basal cell carcinoma) within 5 years before screening;
) Edema of lower limbs or edema of the whole body;
) Moderate to severe renal insufficiency \[ Calculated eGFR\<60 ml/ ( min\*1.73m2 ) using CKD - EPI formula \];
) urinary albumin-to-creatinine ratio of \> 300 mg /g;
) Triglyceride\> 5.6 mmol /L;
) Active liver disease and /or obvious liver function abnormalities, defined as AST\>2.5 times the upper limit of normal value and/or ALT\>2.5 times the upper limit of normal value and/or total bilirubin \>1.5 times the normal value Upper limit
) Clinically significant arrhythmias in the electrocardiogram examination and treatment or intervention are required. The investigator judges that it is not suitable to participate in this clinical trial;
) Human immunodeficiency virus (HIV) antibody-positive; Treponema pallidum antibody positive; positive hepatitis B surface antigen and HBV DNA quantification values were higher than the upper; HCV antibodies and HCV RNA quantification values were higher than the upper ;
) History of illegal drug abuse within 12 months before screening ;
) Participated in other clinical trials within 90 days before screening ;
) Donated whole blood, plasma, or platelets within 3 months before screening.
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chipscreen Biosciences, Ltd.lead

Study Sites (50)

Hefei Second People's Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Beijing Chaoyang Hospital, Capital Medical University